Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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ADVIA®120/2120/2120i TESTpoint™ Retic High Control
Siemens Healthcare Diagnostics Inc.
10312295
In Commercial Distribution

  • 00630414224442 ()
T03-3691-54

  • Reticulocyte count IVD, control
ADVIA®120/2120/2120i TESTpoint™ High Control
Siemens Healthcare Diagnostics Inc.
10312291
In Commercial Distribution

  • 00630414224404 ()
T03-3688-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i Testpoint™ Norm Control
Siemens Healthcare Diagnostics Inc.
10312289
In Commercial Distribution

  • 00630414224381 ()
T03-3687-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10312283
In Commercial Distribution

  • 00630414224329 ()
T03-3682-54

  • Full blood count IVD, calibrator
ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10319591
In Commercial Distribution

  • 00630414224305 ()
T03-3682-01

  • Full blood count IVD, calibrator
Setpoint - ADVIA Chem. - CAL - 12x3mL
Siemens Healthcare Diagnostics Inc.
10312279
In Commercial Distribution

  • 00630414223414 ()
  • 00630414003474 ()
T03-1291-62

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10316869
In Commercial Distribution

  • 00630414223032 ()
T01-3664-01

  • Wash/cleaning solution IVD, automated/semi-automated system
IVD Complete Blood Count Kit CN-FREE
Siemens Healthcare Diagnostics Inc.
10341169
In Commercial Distribution

  • 00630414222950 ()
T01-3626-52

  • Full blood count IVD, kit, cell count
ADVIA®120/2120/2120i DEFOAMER
Siemens Healthcare Diagnostics Inc.
10312274
In Commercial Distribution

  • 00630414222943 ()
T01-3625-54

  • Full blood count IVD, reagent
ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10312272
In Commercial Distribution

  • 00630414222929 ()
T01-3623-01

  • Wash/cleaning solution IVD, automated/semi-automated system
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